Bardy Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bardy Diagnostics, Inc.” (first 2014, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. Since 2017 the median was 30 days, against 198 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Baxter, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 59 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 3 | 30 |
| 2020 | 1 | 30 |
| 2021 | 1 | 30 |
| 2022 | 0 | — |
| 2023 | 1 | 56 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bardy Diagnostics, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Bardy Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233110 | Carnation Ambulatory Monitor | DSH | 2023-11-22 | 56 |
| K210036 | Carnation Ambulatory Monitor (CAM) | DSH | 2021-02-05 | 30 |
| K200870 | Carnation Ambulatory Monitor | DSH | 2020-05-01 | 30 |
| K192556 | Carnation Ambulatory Monitor | DSH | 2019-10-17 | 30 |
| K191471 | Carnation Ambulatory Monitor | DSH | 2019-08-30 | 88 |
| K191000 | Carnation Ambulatory Monitor | DSH | 2019-05-16 | 30 |
| K143067 | Carnation Ambulatory Monitor | DSH | 2014-12-22 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Bardy Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bardy Diagnostics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Bardy Diagnostics, Inc.” (first 2014, latest 2023), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bardy Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bardy Diagnostics, Inc. is 30 days. Since 2017: 30 days, versus 198 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bardy Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 7).
Next steps
- See all 7 Bardy Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSH, Bardy Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.